BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOCKING RECONSTRUCTION PLATE/20 HOLES/160MM

    MDR report key: 5964027 · Received September 20, 2016

    Report

    Report Number
    2520274-2016-14593
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Report Date
    September 2, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE: HWC. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LOT NUMBER WAS IDENTIFIED UPON RECEIPT OF SUBJECT DEVICE. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 9870357. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: AUG 3, 2015. THE REVIEW REVEALED NO COMPLAINT RELATED ANOMALIES. THE REVIEW SHOWS THIS LOT OF TI LOCKING RECONSTRUCTION PLATE 20H/160MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE TITANIUM LOCKING RECONSTRUCTION PLATE/20 HOLES/160MM (PART NUMBER: 449.621, LOT NUMBER: 9870357). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING ONLY APPROXIMATELY 135.27 MM OF THE PLATE WAS RETURNED, THEREFORE A PIECE MEASURING 24.63MM-24.83 MM IN LENGTH IS MISSING FROM THE IMPLANT. ADDITIONALLY THE PLATE IS LONGER STRAIGHT; AN INDICATION THE SURGEON WAS MANIPULATING THE PLATE TO BETTER FIT PATIENT¿S ANATOMY. A SHEER FRACTURE WAS NOTED ON THE DISTAL END OF THE PLATE REPRESENTATIVE OF THE LOCATION OF THE BREAKAGE. THE COMPLAINT CONDITION WAS CONFIRMED. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. CALIPERS USED FOR ALL MEASUREMENTS. A REVIEW OF THE CURRENT DESIGN DRAWING AND AVAILABLE HISTORY FOR THE TOP LEVEL DRAWING FOR THE PLATE WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED IMPLANT'S LOT NUMBER AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A DEFINITIVE ROOT CAUSE OF THE PLATE BREAKAGE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT EXCESSIVE INTRAOPERATIVE BENDING WEAKENED THE PLATE THEREBY CAUSING IT TO FAIL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE A PLATE BROKE DURING BENDING. THE PATIENT HARM OR SURGICAL DELAY IS UNKNOWN. CONCOMITANT DEVICE: BENDING INSERT SCREW, PART# 497.689, LOT# UNKNOWN, QTY UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 22, 2016. IT WAS FURTHER REPORTED THAT THE PLATE BROKE DURING BENDING INTRAOPERATIVELY ON THE BACK TABLE ON AN UNKNOWN DATE FOR AN INITIAL PECTUS PROCEDURE. THE PLATE WAS BEING CONTOURED AND IT WAS NOTED THERE WAS AN INSTABLE SECTION WHICH SUBSEQUENTLY BROKE OFF. THE FRAGMENTS THAT WERE GENERATED FROM THE BREAK WERE OUTSIDE THE PATIENT FIELD AND THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PLATE OF THE SAME PART NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614992 TI LOCKING RECONSTRUCTION PLATE/20 HOLES/160MM PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 9870357

    Patients

    Seq Age Sex Outcome Treatment
    1 PART# 497.689, LOT# UNKNOWN, QTY UNKNOWN